MacCormick Lauren M, Chen Frank, Gilbertson Jeff, Khan Sikandar, Schroder Lisa K, Bechtold Joan E, Cole Peter A
University of Minnesota, Department of Orthopaedic Surgery, 2512 S. 7th St., R200, Minneapolis, MN 55454, United States.
Excelen Center for Bone & Joint Research and Education, 700 10th Avenue South, Minneapolis, MN 55415, United States.
Injury. 2019 Feb;50(2):251-255. doi: 10.1016/j.injury.2018.07.011. Epub 2018 Jul 18.
INFIX and Pelvic Bridge are two new minimally invasive surgical techniques for unstable pelvic ring injuries, and they have demonstrated early clinical success in small, single-center case-series. The primary objective of this study is to gather evidence speaking to the biomechanical stability of internal bridging methods relative to external fixation, with the expectation of biomechanical equivalence.
Ten human cadaveric pelvic specimens were dissected free of all skin, fat, organs, and musculature and were prepared with a partially unstable pelvic ring injury (OTA/AO 61-B). The specimens were randomized to two groups and were repaired and tested with anterior pelvic external fixation (APEF) and INFIX sequentially, or APEF and Pelvic Bridge sequentially. Testing was performed with each specimen mounted onto a servo-hydraulic testing frame with axial compression applied to the superior base of the sacrum under five axial loading/unloading sinusoidal cycles between 10 N and 1000 N at 0.1 Hz. Relative translational motion and rotation across the osteotomy site was reported as our primary outcome measures. Outcome measures were further analyzed using a Wilcoxon signed-rank test to determine differences between non-parametric data sets with significance defined as a p value < 0.05.
We found no statistical difference in translation (p = 0.237, 0.228) or rotation (p = 0.278, 0.873) at the fracture site when comparing both new constructs to external fixation. Under the imposed loading protocol, no episodes of implant failure or failure at the bone-implant interface occurred.
Our study provides the biomechanical foundation necessary to support future clinical trial implementation for pelvic fracture patients. While biomechanical stability of these newer, subcutaneous techniques is equivalent to APEF, the surgeon must take into account their technical abilities and knowledge of pelvic anatomy, patient-specific factors including body habitus, and the potential complications associated with each implant and the ability to avoid them.
INFIX和骨盆桥接是用于不稳定骨盆环损伤的两种新型微创手术技术,它们在小型单中心病例系列研究中已显示出早期临床成功。本研究的主要目的是收集证据,说明内固定桥接方法相对于外固定的生物力学稳定性,期望达到生物力学等效性。
对10个新鲜人体骨盆标本进行解剖,去除所有皮肤、脂肪、器官和肌肉组织,并造成部分不稳定的骨盆环损伤(OTA/AO 61-B)。将标本随机分为两组,依次采用前路骨盆外固定(APEF)和INFIX或APEF和骨盆桥接进行修复和测试。每个标本安装在伺服液压测试框架上,在0.1Hz的频率下,在10N至1000N之间进行5个轴向加载/卸载正弦循环,对骶骨上基部施加轴向压缩。报告截骨部位的相对平移运动和旋转作为主要结局指标。使用Wilcoxon符号秩检验进一步分析结局指标,以确定非参数数据集之间的差异,显著性定义为p值<0.05。
将两种新构建物与外固定进行比较时,我们发现骨折部位的平移(p = 0.237,0.228)或旋转(p = 0.278,0.873)无统计学差异。在施加的加载方案下,未发生植入物失效或骨-植入物界面失效的情况。
我们的研究为支持未来骨盆骨折患者的临床试验实施提供了必要的生物力学基础。虽然这些更新的皮下技术的生物力学稳定性与APEF相当,但外科医生必须考虑其技术能力和骨盆解剖知识、包括体型在内的患者特定因素,以及与每种植入物相关的潜在并发症及其避免能力。